Trans-abdominal Fetal Pulse Oximetry: Tissue Light Scattering

Raydiant Oximetry

Status: Terminated

Conditions: Fetal Distress

Treatments: Device: ISS Device

Study type: Observational

Funder types: Industry

Identifiers

NCT04081584

ISS

Details and patient eligibility

About

This study is being conducted to study light scattering properties of maternal-fetal tissue.

Full description

The ISS customized commercial frequency domain oximeter is used to obtain light scattering information from the maternal abdomen for 10-20 minutes preoperatively and postoperatively in subjects who are having a scheduled C-section.

Enrollment: 4 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Pregnant women with singleton pregnancies, vertex or breech presentation, scheduled for non-emergent cesarean delivery, including cesarean delivery for failure to progress with reassuring electronic fetal heart rate tracing
2. Age greater than or equal to 18 years of age.
3. Healthy women at equal to or greater than 36 weeks gestation undergoing non-emergency cesarean delivery
4. Spinal or epidural anesthesia

Exclusion criteria

1. Emergency cesarian delivery
2. Non-reassuring fetal heart rate tracing
3. Less than 18 years of age
4. Multiple gestation (twins, triplets)
5. Presentation other than vertex or breech
6. Less than 36 weeks of gestation
7. General anesthesia